each country. These control the whole process
of product approval from application formats to
pricing. A small exception is in Egypt, where
the regulatory authority is subdivided; the National
Organization for Drug Control and Research
(NODCAR) works together with the Central
Administration for Pharmaceutical Affairs
(CAPA) and the Drug Policy and Planning Centre
(DPPC), all being within the Ministry of Health
and Population (MoHP).
Realizing the benefits of harmonization, the fol-
lowing countries now accept a standard format mar-
keting application: Saudi Arabia, Bahrain, Kuwait,
Oman, Qatar and UAE. These are coordinated by
the Gulf Central Committee for Drug Registration
(GCC-DR). In August 2004, applications could be
submitted to the GCC-DR, and a two-year transition
to this becoming mandatory was under discussion.
Otherwise, nation-by-nation applications within the
GCC-DR territory are made, and most companies
taking this regulatory route prepare their dossiers to
a standard acceptable in Saudi Arabia, which prob-
ably has the most rigourous review system in the
region (see also the Appendix).
Other organizations involved
in regulatory affairs and health policy
TheLevant Industry Group, founded in 1995, is
headquartered in Amman, Jordan.
Its objective is to represent the pharmaceutical
industry in dialogue with governments in health-
care issues. Its membership includes pharmaceuti-
cal companies that are active in Cyprus, Jordan,
Lebanon and Palestine.
ThePharmaceutical Research and Manufactur-
ing Affiliates(PhRMAG) was founded in 1999, and
is based in Dubai (UAE). Its objective is to repre-
sent the pharmaceutical industry in dialogue with
governments in healthcare issues and to commu-
nicate the value of innovation and research. Its
membership is mainly the Middle East affiliates
of European and American pharmaceutical com-
panies that are active in the five Gulf States
(Kuwait, Bahrain, Qatar, UAE and Oman).
TheMiddle East Regulatory Conference(MERC)
wasfounded in 1995 by the pharmaceuticalindustry.
It meets annually in different countries by rotation
(most recently Dubai, Cyprus, Bahrain and Egypt).
The objectives of the MERC are to facilitate com-
munication between the regulatory authorities and
the industry, to understand and discuss registration
requirements and their relevance, to provide updates
on new trends and concepts, to align perceptions of
both the industry and authority, to facilitate discus-
sions on current and key issues, to seek solutions,
and generally to continue to build trust and partner-
ships between industry and authorities.36.2 Company and product
registrationThe registration process of pharmaceutical products
in the Middle Eastern countries differs from all other
regions of the world in that an additional company
registration is required in addition to individual
product applications. The company registration
includes documentation for each manufacturing
site and all the relevant company subsidiaries. In
some countries, this company registration must be
approved prior toproduct registration (Saudi Arabia,
Bahrain, Oman, Syria, Iraq and Yemen), whereas
elsewhere company and product registration appli-
cations can be filed in parallel (Egypt, Kuwait,
Qatar, UAE, Jordan and Lebanon). Some countries
(e.g. Saudi Arabia and Yemen) make inspections
during or after the company registration process.
Applicants in these countries can expect to pay the
costs for two or three inspectors for the duration of
that inspection, which usually lasts for about a week.General requirements for company
registrationDocumentation for submission:Application form/questionnaire, which is coun-
try specific. Information pertaining to the com-
pany size, staff, equipment, production and
quality control.Company profile.510 CH36 DRUG REGISTRATION AND PRICING IN THE MIDDLE EAST